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Model Number UNK PELVICOL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Fatigue (1849); Incontinence (1928); Nausea (1970); Vomiting (2144); Weakness (2145); Injury (2348); Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Date received by mfr: since the lot number was not provided, this information cannot be determined.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative and postoperative diagnosis was stress urinary incontinence, cystocele, and rectocele.The procedure performed was an anterior and posterior vault with pubovaginal sling with mesh and cysto.The patient underwent an additional procedure on (b)(6) 2007.The preoperative and postoperative diagnosis was stress urinary incontinence.The procedure performed was a cystoscopy and pubovaginal sling.The patient underwent and additional procedure on (b)(6) 2007.The diagnosis was incontinence.The procedure performed was a collagen procedure.She did not have vaginal bleeding until she saw a suture and pulled on it and some tissue came out and she started to have some vaginal bleeding.She also has had a bad upper respiratory infection and had severe nausea, vomiting, poor appetite, weakness, fatigue, and heavy coughing.She felt something "break lose".She was taken back to the operating room (or) (b)(6) 2007 and the prolene suture had pulled out of her sling.The sling was repaired.She developed an abscess on her abdomen incision postop.It was drained and she did dressing changes daily.She was leaking again and urodynamic testing was repeated.
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Manufacturer Narrative
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Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative and postoperative diagnosis was stress urinary incontinence, cystocele, and rectocele.In 2006 the procedure performed was an anterior and posterior vault with pubovaginal sling with mesh and cysto with pelvicol under general anesthesia.The patient underwent cystoscopy, pubovaginal sling (using pelvicol) for stress urinary incontinence under general anesthesiaon (b)(6) 2007.The preoperative and postoperative diagnosis was stress urinary incontinence.The procedure performed was a cystoscopy and pubovaginal sling.Patient had suture and pulled it on and some tissue and started some vaginal bleeding.Urodynamics on (b)(6) 2007 showed recurrent stress urinary incontinence, diminished bladder capacity, increased bladder sensation.Assessed with stress urinary incontinence.Underwent collagen injection with cystoscopy.The patient underwent and additional procedure on (b)(6) 2007.The diagnosis was incontinence.The procedure performed was a collagen procedure.She did not have vaginal bleeding until she saw a suture and pulled on it and some tissue came out and she started to have some vaginal bleeding.She also has had a bad upper respiratory infection and had severe nausea, vomiting, poor appetite, weakness, fatigue, and heavy coughing.She felt something "break lose".She was taken back to the operation room (b)(6) 2007 and the prolene suture had pulled out of her sling.The sling was repaired.She developed an abscess on her abdomen incision postop.It was drained and she did dressing changes daily.She was leaking again and urodynamic testing was repeated.
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Search Alerts/Recalls
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